- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01057797
Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)
2010년 1월 26일 업데이트: University of Illinois at Chicago
Nurse Managed Upper Body Strength Training in COPD
This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up.
연구 개요
상태
완전한
정황
상세 설명
People with moderate to severe chronic obstructive pulmonary disease (COPD) experience intense symptoms of dyspnea when they use their arms and shoulders.
To control dyspnea they avoid using their arms and ultimately experience a significant loss of upper body (UB) strength and a decrease in the level of physical activity.
Some pulmonary rehabilitation programs include strength training, but the training intensity is typically very low.
The purpose of this research is to examine the effects of UB strength training (designed to maximize strength gains) with a self-confidence intervention to enhance adherence to exercise.
This is an experimental study with random assignment of subjects to one experimental and two control groups: (a) UB strength training and self-efficacy intervention for adherence (experimental), (b) UB strength training with health education (control 1) and (c) gentle armchair fitness exercises with health education (control 2).
Each subject will be studied for a total of 16 months.The intervention period is four months in duration with a 12-month follow-up period.
The sample will be people with moderate to severe COPD who experience dyspnea with UB activities.
This research is innovative in that it examines the effects of upper body strength training designed to maximize strength gains and combines it with a theory-based self-efficacy (confidence-building) intervention to promote adherence to training in people with COPD.
연구 유형
중재적
등록 (실제)
208
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
45년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- FEV1/FVC < 70 and FEV1 < 80%
- > or = 45 years of age
- Currently in stable clinical condition [free of respiratory tract infections for at least two months prior to enrollment, no recent change in the color, consistency, or quantity of sputum, afebrile and no recent change in medical therapy]
- Taking appropriate medications according to the GOLD standards
- Experience dyspnea with the use of their arms.
Exclusion Criteria:
- Evidence of restrictive lung disease or asthma
- Acute respiratory infection
- Taking oral corticosteroids on a regular basis
- >3 exacerbations in the previous year
- Evidence of significant depression (Hospital Anxiety Depression Scale >10)
- Presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis, evidence of alcohol or drug abuse, diabetes requiring insulin therapy, musculoskeletal or degenerative nerve disease, etc.
- Presence of a condition that would make it potentially unsafe to exercise, including a history of a recent myocardial infarction, unstable angina pectoris, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, severe symptomatic aortic stenosis, uncontrolled symptomatic heart failure, uncontrolled metabolic disease, abnormal response to exercise test
- Currently participating in pulmonary rehabilitation.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Upper Body Strength Training with Self-Efficacy
16 weeks of upper body strength training combined with an exercise-specific self-efficacy enhancing intervention
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Subjects in the experimental group will participate in a self-efficacy enhancing intervention designed to maximize (a) exercise-specific SE-UB strength training (b) self-efficacy for overcoming barriers to exercise and (c) SE-UB physical activities.
The intervention incorporates strategies to maximize the primary sources of efficacy information: (a) mastery accomplishments, (b) social modeling, (c) social persuasion, (d) interpretation of physiological and affective symptoms.
16 weeks of lab-based upper body strength training using 8: modified lateral pull down, shoulder shrug, upright row, overhead pull down, front raise, front pull down, triceps extension, biceps curl.
Training load and volume will be increased progressing from 70% to 80% of the maximum strength training and from 2 sets of 8-10 repetitions progressing to 3 sets.
Each week subjects will train twice in the lab and once at home.
Home exercises will include 1 set of 15-20 repetitions: biceps curl, triceps extension, front raises, lateral raises, overhead press, chest press and one-arm dumbbell row.
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활성 비교기: Upper body strength training
16 weeks of upper body strength training with weekly health education sessions
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16 weeks of lab-based upper body strength training using 8: modified lateral pull down, shoulder shrug, upright row, overhead pull down, front raise, front pull down, triceps extension, biceps curl.
Training load and volume will be increased progressing from 70% to 80% of the maximum strength training and from 2 sets of 8-10 repetitions progressing to 3 sets.
Each week subjects will train twice in the lab and once at home.
Home exercises will include 1 set of 15-20 repetitions: biceps curl, triceps extension, front raises, lateral raises, overhead press, chest press and one-arm dumbbell row.
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가짜 비교기: Chair exercise
16 wks of gentle chair exercise with weekly health education
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Gentle armchair fitness exercises will be used as a sham treatment to control for the attention that subjects receive in the two strength training groups.
The armchair fitness exercises will be conducted in small groups (n=8-10 per group).
Armchair exercises will include stretching of all major joints with an emphasis on the arms and shoulders, massage of muscles that can be reached from the armchair (scalp, neck, shoulders, lower back, abdomen and thighs) and imagery to promote relaxation.
Each session will include: 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery for relaxation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Upper body strength
기간: before training, after training, 6 months post training, 12 months post training
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before training, after training, 6 months post training, 12 months post training
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Dyspnea
기간: before training, after training, 6 months post training, 12 months post training
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before training, after training, 6 months post training, 12 months post training
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Functional performance
기간: before training, after training, 6 months post training, 12 months post training
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before training, after training, 6 months post training, 12 months post training
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Exercise adherence
기간: before training, after training
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before training, after training
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Janet L Larson, PhD, RN, University of Illinois at Chicago and University of Michigan
- 연구 책임자: Margaret K Covey, PhD, RN, University of Illinois at Chicago
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2003년 9월 1일
기본 완료 (실제)
2009년 1월 1일
연구 완료 (실제)
2009년 1월 1일
연구 등록 날짜
최초 제출
2010년 1월 26일
QC 기준을 충족하는 최초 제출
2010년 1월 26일
처음 게시됨 (추정)
2010년 1월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2010년 1월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 1월 26일
마지막으로 확인됨
2010년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .